FDA leaves out Pfizer COVID vaccine 'stroke signal,' myocarditis study from advisers' next meeting

"Pfizer was legally obligated to study troponin elevations in young men who got the shot," epidemiologist notes. Study was due Dec. 31.

Updated: January 24, 2023 - 11:49am

The FDA's briefing documents for the next meeting of its outside advisers specializing in COVID-19 vaccines have a couple big omissions, agency watchers say.

Pfizer's promised study on "subclinical myocarditis" in young adults who received its original booster, which was due Dec. 31 at the agency, and the "stroke signal" the feds detected, then dismissed in elderly recipients of Pfizer's new booster are not mentioned.

The CDC and FDA will each make a presentation on the "effectiveness and safety" of the original and Omicron-targeting vaccines. The Centers for Disease Control and Prevention's is 45 minutes, and the Food and Drug Administration's is 30 minutes.

Each includes five minutes of questions and answers from Vaccines and Related Biological Products Advisory Committee members.

"Remember Pfizer was legally obligated to study troponin elevations in young men who got the shot," University of California San Francisco epidemiologist Vinay Prasad wrote in his newsletter Monday. "This is different that [sic] clinical myocarditis— this is heart damage that these young healthy men may not feel or may ignore, and is much more common."

The FDA has not responded to Just the News queries Monday afternoon about the omissions or a reminder Tuesday morning.

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